FDA Advocates Offsite Trial Data Storage Best Practices

Sponsors who allow clinical research coordinators (CRCs) to store clinical trial records at home would be well-advised to spell out the policy details in the protocol, says Doreen M. Kezer, MSN, a senior health policy analyst, Office of Good Clinical Practice, Office of the Commission, Food and Drug Administration (FDA). It should “probably state how […]

All of Us Research Program Logo

National Institutes of Health Launches ‘All of Us’ Research Program

Precision medicine has been a buzzword in healthcare circles for years now, but the National Institutes of Health (NIH) is poised to launch a major new research effort that will make it a reality. The All of Us Research Program seeks to enroll one million or more participants who will share their health information and […]

Tom Krohn, Chief Development Officer, Antidote

Patient Centricity in Clinical Trials: Where Do We Go Next?

This article is the first in a series on patient centricity in clinical trials.  Over the last few years, clinical research organizations have piloted and explored a number of innovations in the hopes that new ideas—from wearables to social media recruitment—would improve the efficiency of conducting clinical trials. While there has been some progress and […]

Clinical Trial Data Sources Poised for Spike

The volume and diversity of data sources used in clinical trials are expected to skyrocket for the rest of the decade, according to new research from Tufts Center for the Study of Drug Development. In the second report from the 2017 eClinical Landscape Study, 97% of companies say they will increase their use of at least one […]